COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
Class I - DangerousWhat Should You Do?
- Check if you have this product: GTIN: 00763000178093, Serial Number: RTC656756S; GTIN: 00763000178116, Serial Numbers: RTC656044S, RTC656047S, RTC656049S, RTC656061S, RTC656065S, RTC656070S, RTC656072S, RTC656099S, RTC656100S, RTC656102S, RTC656103S, RTC656104S, RTC656105S, RTC656106S, RTC656107S; GTIN: 00763000711160, Serial Numbers: RTC655925S, RTC655928S, RTC655930S, RTC655931S, RTC655932S, RTC655938S, RTC655945S, RTC655947S, RTC655950S, RTC655964S, RTC655971S, RTC656073S, RTC656074S, RTC656076S, RTC656077S, RTC656078S, RTC656080S, RTC656082S, RTC656087S, RTC656090S, RTC656093S, RTC656095S, RTC656096S, RTC656587S, RTC656589S, RTC656590S, RTC656592S, RTC656602S, RTC656603S, RTC656606S, RTC656607S, RTC656608S, RTC656609S, RTC656610S, RTC656615S, RTC656616S, RTC656619S, RTC656625S, RTC656626S, RTC656627S, RTC656628S, RTC656630S
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Inc.
- Reason for Recall:
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator
Product Codes/Lot Numbers:
GTIN: 00763000178093, Serial Number: RTC656756S; GTIN: 00763000178116, Serial Numbers: RTC656044S, RTC656047S, RTC656049S, RTC656061S, RTC656065S, RTC656070S, RTC656072S, RTC656099S, RTC656100S, RTC656102S, RTC656103S, RTC656104S, RTC656105S, RTC656106S, RTC656107S; GTIN: 00763000711160, Serial Numbers: RTC655925S, RTC655928S, RTC655930S, RTC655931S, RTC655932S, RTC655938S, RTC655945S, RTC655947S, RTC655950S, RTC655964S, RTC655971S, RTC656073S, RTC656074S, RTC656076S, RTC656077S, RTC656078S, RTC656080S, RTC656082S, RTC656087S, RTC656090S, RTC656093S, RTC656095S, RTC656096S, RTC656587S, RTC656589S, RTC656590S, RTC656592S, RTC656602S, RTC656603S, RTC656606S, RTC656607S, RTC656608S, RTC656609S, RTC656610S, RTC656615S, RTC656616S, RTC656619S, RTC656625S, RTC656626S, RTC656627S, RTC656628S, RTC656630S
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2194-2024
Related Recalls
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.